Rheumatoid arthritis
Conditions
Interventions
Arm 1:Subcutaneous injection
Arm2 :Subcutaneous injection
Arm 3:Subcutaneous injection
Arm 4:Subcutaneous injection
Arm 5:Subcutaneous injection
Arm 6:Subcutaneous injection
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Those who meet all of the following criteria are eligible for this test: 1. Understand the test steps and content, and voluntarily sign informed consent; 2. Male and female Chinese healthy adult volunteers aged from 18 to 45 years; 3. Physical fitness according to the requirements within 30 days before the test, i.e. body weight index (BMI) is in the range of 19 ~ 24 and the weight is 45 ~ 75 kg; 4. Persons who agree to take medically recognized and effective contraceptives throughout the test period and within 6 months after the end of the test; 5. According to physical examination, medical history, vital signs, ECG, etc., the researchers determine that the subjects are in good health; 6. Patients have good compliance, can be visited as scheduled and are able to communicate with the researchers in good faith and complete the study in accordance with the provisions of research.;Inclusion criteria: Those who meet all of the following criteria are eligible for this test: 1. Understand the test steps and content, and voluntarily sign informed consent; 2. Male and female Chinese healthy adult volunteers aged from 18 to 45 years; 3. Physical fitness according to the requirements within 30 days before the test, i.e. body weight index (BMI) is in the range of 19 ~ 24 and the weight is 45 ~ 75 kg; 4. Persons who agree to take medically recognized and effective contraceptives throughout the test period and within 6 months after the end of the test; 5. According to physical examination, medical history, vital signs, ECG, etc., the researchers determine that the subjects are in good health; 6. Patients have good compliance, can be visited as scheduled and are able to communicate with the researchers in good faith and complete the study in accordance with the provisions of research.;Inclusion criteria: Those who meet all of the following criteria are eligible for this test: 1. Understand the test steps and content, and voluntarily sign informed consent; 2. Male and female Chinese healthy adult volunteers aged from 18 to 45 years; 3. Physical fitness according to the requirements within 30 days before the test, i.e. body weight index (BMI) is in the range of 19 ~ 24 and the weight is 45 ~ 75 kg; 4. Persons who agree to take medically recognized and effective contraceptives throughout the test period and within 6 months after the end of the test; 5. According to physical examination, medical history, vital signs, ECG, etc., the researchers determine that the subjects are in good health; 6. Patients have good compliance, can be visited as scheduled and are able to communicate with the researchers in good faith and complete the study in accordance with the provisions of research.;Inclusion criteria: Those who meet all of the following criteria are eligible for this test: 1. Understand the test steps and content, and voluntarily sign informed consent; 2. Male and female Chinese healthy adult volunteers aged from 18 to 45 years; 3. Physical fitness according to the requirements within 30 days before the test, i.e. body weight index (BMI) is in the range of 19 ~ 24 and the weight is 45 ~ 75 kg; 4. Persons who agree to take medically recognized and effective contraceptives throughout the test period and within 6 months after the end of the test; 5. According to physical examination, medical history, vital signs, ECG, etc., the researchers determine that the subjects are in good health; 6. Patients have good compliance, can be visited as scheduled and are able to communicate with the researchers in good faith and complete the study in accordance with the provisions of research.;Inclusion criteria: Those who meet all of the following criteria are eligible for this test: 1. Understand the test steps and content, and voluntarily sign informed consent; 2. Male and female Chinese healthy adult volunteers aged from 18 to 45 years; 3. Physical fitness according to the requirements within 30 days before the test, i.e. body weight index (BMI) is in the range of 19 ~ 24 and the weight is 45 ~ 75 kg; 4. Persons who agree to take medically recognized and effective contraceptives throughout the test period and within 6 months after the end of the test; 5. According to physical examination, medical history, vital signs, ECG, etc., the researchers determine that the subjects are in good health; 6. Patients have good compliance, can be visited as scheduled and are able to communicate with the researchers in good faith and complete the study in accordance with the provisions of research.
Exclusion criteria
Exclusion criteria: Those who meet one of the following conditions will not be included in this test: 1. Persons with allergic constitution; persons who are known to be allergic to the ingredients of test drug or have food allergic history or pollen allergic history; persons with physical urticaria and other skin allergy history; persons with abnormality in serum immunoglobulin E (IgE) examination; anyone in line with any one of the items above. 2. Any symptoms, signs or abnormalities in the laboratory tests indicating that there may be acute or sub-acute infected persons (such as fever, cough, urgent urination, dysuria, abdominal pain, diarrhea, skin infections, etc.); 3. On inquiry, persons with active tuberculosis infection; or previous history of active tuberculosis infection; 4. On inquiry, persons with drug addiction history or substance abuse; 5. Persons with unequivocal medical history of central nervous system, cardiovascular system, kidney, liver, digestive system, respiratory system, metabolic system; persons with history of high blood pressure or systolic pressure =140 mmHg and/or diastolic pressure =90 mmHg during selection and clinical significance judged by researchers; persons with history of postural hypotension; 6. Persons with history of malignant tumor; 7. Persons who have participated in other clinical tests of drugs within 3 months before being included in the group or have taken the drugs which have the known damage to main visceral organs within previous 3 months; 8. Persons who have taken prescription or nonprescription drugs within 14 days before being included in the group; 9. Persons with the history of blood donation within 3 months before being included in the group; 10. Persons in line with any item of followings: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 times of the upper limit of normal (ULN) and serum creatinine (Cr)> upper limit of normal; 11. Persons in line with any item of followings: abnormalities in blood routine examination: white blood cell (WBC) 9.5×10^9/L, neutrophile granulocyte (ANC) 1.5 times of the upper limit of normal (ULN) and serum creatinine (Cr)> upper limit of normal; 11. Persons in line with any item of followings: abnormalities in blood routine examination: white blood cell (WBC) 9.5×10^9/L, neutrophile granulocyte (ANC) 1.5 times of the upper limit of normal (ULN) and serum creatinine (Cr)> upper limit of normal; 11. Persons in line with any item of followings: abnormalities in blood routine examination: white blood cell (WBC) 9.5×10^9/L, neutrophile granulocyte (ANC) 1.5 times of the upper limit of normal (ULN) and serum creatinine (Cr)> upper limit of normal; 11. Persons in line with any item of followings: abnormalities in blood routine examination: white blood cell (WBC) 9.5×10^9/L, neutrophile granulocyte (ANC) 1.5 times of the upper limit of normal (ULN) and serum creatinine (Cr)> upper limit of normal; 11. Persons in line with any item of followings: abnormalities in blood routine examination: white blood cell (WBC) 9.5×10^9/L, neutrophile granulocyte (ANC) < 1.5×10^9/L, blood platelet count (PLT) < 100×10^9/L, hemoglobin (HGB) < 104 g/L; 12. Persons in line with any item of followings: positive result of hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), acquired immunodeficiency syndrome (Anti-HIV) and anti-Treponema pallidum antibody (TP-Ab); 13. in tuberculin skin test (5 unit dose, induration reading for 48 to 72 hours = 5 mm); 14. Persons with positive result of anti-nuclear antibody (ANA), anti-double-stranded DNA (ds-DNA), anti-soluble antigen antibody (ENA); 15. Persons with positive result of drug-resistant antibody (ADA); 16. Persons with positive result of tumor marker (CEA, AFP, PSA, CA-125); 17. Persons with coagulation dysfunction and clinical significance judged by researchers; 18. Persons with psychiatric history; 19. On inquiry, persons smoking 5 cigarettes/day or equivalent; 20. On inquiry, persons drinking 28 units/week (1 unit = 285 ml of beer or 25 ml of spirit or a glass of wine); or persons with positive result in the breath alcohol test within 24 hours before receiving the drugs; 21. Persons with abnormal values of laboratory inspection with clinical significance during selection; 22. Female subjects with positive result in blood/urine pregnancy test or within suckling period during selection. 23. Patients with insufficient communication, understanding and cooperation and
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-t;Cmax;AUC0-8;Tmax;Vd;t1/2;CL;Ke; | — |
Countries
China
Contacts
Public ContactFiona Cheng;Fiona Cheng;Fiona Cheng;Fiona Cheng;Fiona Cheng ;;;;
Genor Biopharma Co. Ltd.;Genor Biopharma Co. Ltd.;Genor Biopharma Co. Ltd.;Genor Biopharma Co. Ltd.;Genor Biopharma Co. Ltd.
Outcome results
None listed